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OpenTrials
Completed

NCT Number: NCT00240955

Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients

The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.

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Key information

Conditions

Renal Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

/ Exclusion Criteria

  • All patients who completed the core study and who are still receiving the EC-MPS and wish continue treatment with EC-MPS and from whom written informed consent has been obtained

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Primary outcomes

  1. Safety and tolerability of enteric-coated mycophenolate sodium based on adverse event (AE) reporting.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Efficacy and Safety of Two Immunosuppressive Regimens Mycophenolate Sodium (EC-MPS) With Short-term Steroid Use or Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Oct 18, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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